Efficacy And Safety Of CX516 In Elderly Participants With Mild Cognitive Impairment.
Efficacy And Safety Of CX516 (900 mg t.i.d.) In Elderly Participants With Mild Cognitive Impairment. A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group 4-week Study.
1 other identifier
interventional
175
1 country
8
Brief Summary
Glutamate is fundamentally involved in learning and memory. Memory loss associated with mild cognitive impairment may be due to loss of glutamate receptors in the aging brain. There is evidence CX516 enhances brain activity by specifically targeting remaining glutamate receptors in the affected portions of the brain. This study will test the safety and efficacy of CX516 in the symptomatic treatment of participants with mild cognitive impairment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Apr 2002
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2002
CompletedFirst Submitted
Initial submission to the registry
June 26, 2002
CompletedFirst Posted
Study publicly available on registry
June 28, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2004
CompletedResults Posted
Study results publicly available
July 23, 2018
CompletedJuly 23, 2018
October 1, 2017
1.3 years
June 26, 2002
July 27, 2016
October 9, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
15-Item Word List Delayed Recall
The 15-Item Word List delayed recall score is used as a clinical measure of episodic memory, and was the primary outcome variable for this study. Episodic memory of the type addressed by delayed recall of lists and stories (i.e., in the WMS-R logical memory tests and 15-item World List recall tests) is among the earliest deficits during aging and MCI compared to other aspects of cognition (attention, reaction time, language, etc). It was decided to use the 15-item Word List delayed recall test as the primary outcome measure due to its sensitivity in the assessment of MCI. The possible score range for the 15-item Word List Delayed Recall test is 0 to 15. A clinical improvement of MCI or dementia would be characterized by an increase in the score due to an increase in the number of words recalled.
28 Days
Study Arms (2)
CX516
EXPERIMENTALCX516 - 900 mg
Placebo
PLACEBO COMPARATORPlacebo
Interventions
Eligibility Criteria
You may qualify if:
- Clinical diagnosis of mild cognitive impairment
- Good general health with no additional diseases that would interfere with the study.
You may not qualify if:
- Any significant neurologic disease (other than suspected incipient Alzheimer's disease), such as Parkinson's disease, stroke, TIA's, multi-infarct dementia, Huntington's disease, head trauma, chronic CNS infection.
- History of major depression or another major psychiatric disorder within the past 6 months.
- History of schizophrenia, mania or recurrent psychotic episodes.
- History of alcohol or DSM IV-diagnosed substance abuse or dependence disorder within the past year.
- History of blackout, epilepsy or seizures, or an abnormal EEG as judged by the Investigator and considering the age of the participant.
- Any clinically significant hepatic, renal, cardiovascular, pulmonary, gastrointestinal or hematological illness or unstable medical condition which could interfere with drug safety, or absorption, distribution, metabolism and excretion, or lead to difficulty complying with the protocol.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- RespireRxlead
Study Sites (8)
Pivotal Research Centers
Peoria, Arizona, 85381, United States
University of California Irvine
Irvine, California, 92697, United States
University of California at Los Angeles
Los Angeles, California, 90095, United States
University of California, San Diego
San Diego, California, 92093, United States
Yale University School of Medicine
New Haven, Connecticut, 06510, United States
Sun Coast Gerontology Center, University of South Florida
Tampa, Florida, 33617, United States
Mercy Mayo Clinic
Des Moines, Iowa, 50314, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Richard Purcell
- Organization
- RespireRx Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 26, 2002
First Posted
June 28, 2002
Study Start
April 1, 2002
Primary Completion
August 1, 2003
Study Completion
June 1, 2004
Last Updated
July 23, 2018
Results First Posted
July 23, 2018
Record last verified: 2017-10
Data Sharing
- IPD Sharing
- Will not share